Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke

This study has been completed.
Sponsor:
Collaborators:
Dongzhimen Hospital, Beijing
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT00843765
First received: February 12, 2009
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.


Condition Intervention
Stroke
Other: acupuncture, massage and basic TCM treatment
Other: rehabilitation and WM basic treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • NIHSS Stroke Scale, relapse rate [ Time Frame: 360 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse event [ Time Frame: 360 days ] [ Designated as safety issue: Yes ]

Enrollment: 1151
Study Start Date: December 2007
Study Completion Date: November 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TCM integrated group
800 patients with acupuncture, massage and basic Chinese medicine treatment
Other: acupuncture, massage and basic TCM treatment
  1. During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education.
  2. After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes.
Other Name: 863 TCM project for ischemic stroke-TCM group
Active Comparator: Western Medicine group
400 patients with modern rehabilitation techniques and Western Medicine basic treatment
Other: rehabilitation and WM basic treatment

there two steps:

  1. during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education
  2. After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet
Other Name: 863 TCM project for ischemic stroke-WM group

Detailed Description:

As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • According with the stroke diagnosis of Traditional Chinese Medicine
  • According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations
  • It has attacked in 7 days
  • The assessment of scale of NIHSS:4-24 points
  • Age: ≥ 35 years and ≤ 75 years
  • Patients or their legal guardians sign informed consent form

Exclusion Criteria:

  • The patients with ICH or cerebral hemorrhage or TIA
  • It has attacked beyond 7 days
  • Patients with stroke history and the mRS ≥ 2 points before this attack
  • Mixed type of stroke (infarction after bleeding or bleeding after infarction)
  • Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating
  • Patients with serious heart disease;failure of heart or liver or kidney; cancer;digestive tract bleeding
  • Women of pregnancy or breast-feeding
  • Patients who are taking part in other clinical trials that will influence the results of this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843765

Locations
China, Beijing
China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100700
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Dongzhimen Hospital, Beijing
Beijing Tiantan Hospital
Investigators
Principal Investigator: Xie Y m China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT00843765     History of Changes
Other Study ID Numbers: 2007AA02Z4B2
Study First Received: February 12, 2009
Last Updated: February 13, 2012
Health Authority: China: Ministry of Health

Keywords provided by China Academy of Chinese Medical Sciences:
Stroke
Traditional Chinese Medicine
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 15, 2014